FDA.reportPublic FDA data

Kae Miller

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80208933002807850Kae Miller1N2026-01-01200 Medtronic Drive Lafayette CO US 80026
96108493002807391Kae Miller1N2026-01-01200 Medtronic Drive Lafayette CO US 80026
96813843002807626Kae Miller1N2026-01-01200 Medtronic Dr Lafayette CO US 80026
30132427013013242701Kae Miller1N2026-01-01200 Medtronic Drive Lafayette CO US 80026
30232947263023294726Kae Miller1N2026-01-01200 Medtronic Drive Lafayette CO US 80026
30102441873010244187Kae Miller1N2020-04-256135 Gunbarrel Ave Boulder CO US 80301

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
839001362897655P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEMLPB2003-04-17
838991456206063K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODEGEI2000-03-07
838991180842907K993637N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMSDQA1999-11-24
839001683903891K993071PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840CBK1999-11-24
839001602869708K991823N-395 PULSE OXIMETER, MODEL N-395DQA1999-08-25
839001276224940K990897NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZERCAF2000-03-15
839001753591433K984535PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTIONCBK1998-12-28
839001319582337K984379NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEMCBK1998-12-10
838991640260650K981916LIGASURE VESSEL SEALING SYSTEMGEI1998-08-28
838981043247324K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
838981040328427K980324MICROSTREAM FILLERLINE OR/EMSCCK1998-04-16
838992057839441K973419DMR PLUS DISPOSABLE MANUAL RESUSCITATORBTM1998-03-25
839001946715645K973147NPB-295 PULSE OXIMETERDQA1997-11-14
839002000961004K972837NPB-290 PULSE OXIMETER (NPB-290)DQA1997-10-21
839001468543716K972468NPB-195 PULSE OXIMETERDQA1997-09-25
838981939331742K972258HI-CARE CLOSED SUCTION SYSTEMBSY1997-12-29
839001697925354K971946NPB-190 PULSE OXIMETER (NPB-190)DQA1997-08-25
839001247057713K971628SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)DQA1997-10-10
838991927772178K970460NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)CBK1998-04-30
839001927772178K970460NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)CBK1998-04-30
838982015791790K965132HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBESBTR1997-03-20
838992021649290K964540NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEMCBK1997-11-14
839002021649290K964540NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEMCBK1997-11-14
838991466625005K964175VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODESGEI1996-12-05
839001781864299K963707NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)DQA1996-12-13
838981614059379K962173SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESJOH1996-10-04
2191061832043296K962045ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KITCAH1996-11-26
838991899427922K955836VALLEYLAB COATED ELECTRODESGEI1996-02-01
838981612148087K955680SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFEDJOH1996-03-13
838981807255614K954749MALLINCKRODT SHILEY 15MM CAPJOH1996-01-24
839001512209294K952428POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTERCAH1995-07-07
839001801359962K952222NELLCOR N-20PA PORTABLE PULSE OXIMETERDQA1995-08-15
2191061588243808K952036FLEXLIFEBYD1995-06-08
838991666050620K950188VALLEYLAB COATED ELECTRODESGEI1995-02-10
838991877536726K950042SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETERFJS1995-12-15
838992043973424K945964KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETSLZH1995-03-07
838981768700354K945513MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBEJOH1995-01-13
838981340311410K945407SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORTBTO1995-02-27
838981472113617K945406SSV PHONATE(TM) SHILEY SPEAKING VALVEBTO1995-02-27
838991867732670K944760DURA-Y OXYGEN TRANSDUCER, EAR CLIPDPZ1994-10-17
838991374763163K944400PEDI-CAPCCK1994-09-27
838991517400218K944249AUTO SUTURE* ANTI-FOG DEVICE**FEB1994-09-20
2191061546133538K944124SPIROBAC ADAPTERSCAH1994-09-08
2191061340737589K942794HYGROLIFEBYD1994-08-22
2191061226756953K942392AIRWAY CONNECTOR WITH FLEX TUBEBZA1994-08-22
838991786987338K942347NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000DQA1995-05-12
838992006222962K942246PURITAN-BENNETT NASAL CPAP MASKBYE1994-07-06
838991398893780K942183E2550 REUSABLE HANDSWITCHING PENCILGEI1994-05-17
2191061015654582K941676STERIVENT AND STERIVENT SCAH1994-05-20
2191062072756283K941585HYGROSTERBYD1994-04-19
2191062031538333K941536BARRIERBAC AND BARRIERBAC SCAH1994-04-19
2191062071886021K941535TRACHEOLIFEBYD1994-04-15
2191061165825022K941381HYGROBAC,S HYGROBOY AND HYGROBABYCAH1994-04-15
838981112993412K941246RAE II TRACHEAL TUBEBTR1994-04-11
838991355492268K935238ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAYFRG1994-02-17
838992061687143K934428ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAYLRO1993-12-30
838991035601941K933626CAPNO-FLOBTM1993-10-06
838982002012069K930895SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIFJOH1993-07-02
838991695810333K930017PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARDCBK1994-09-22
839001695810333K930017PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARDCBK1994-09-22
838981148959863K925615SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBECBI1993-03-26
838991195784245K922468ANGEL WING SETS -- MODIFIEDGIM1992-07-10
838991580800185K921054KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.KOD1992-09-23
838992044752678K920515INSERTIONFJS1992-05-04
838991927714574K920184ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.GIM1992-02-18
839001425177671K915699NELLCOR PORTABLE PULSE OXIMETER MODEL N-20DQA1993-05-27
838981240918089K914887ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCTFRQ1992-05-08
838991846243573K914375NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBEKNT1992-03-06
838991880033863K913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170BZQ1992-07-02
838991263815481K913016WARMTOUCHDWJ1991-09-04
838991553873297K912563ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SEFOZ1991-10-02
838981341609698K912240CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEMBYE1991-08-22
838992012318789K910786TROCAR (FALLER STYLET)FJS1991-09-19
838991272955125K904560VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODESGEI1990-12-31
838991348720356K904039REFLECTANCE SENSOR (RS-10)DQA1990-12-27
838981812419663K903435SHILEY SPECIALIZED TRACHEOSTOMY TUBEJOH1990-10-02
838991487281483K903340STERILE URETHRAL CATHETER PROCEDURE KITSFCM1990-10-04
839001878347054K903010CONTINUOUS VOLUME VENTILATOR MODEL LP10CBK1990-11-30
838981442793998K900164AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.BYE1990-01-26
838991442793998K900164AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.BYE1990-01-26
838981343881754K895875MODEL 4070 TEMPERATURE MONITORFLL1989-12-21
838991834446846K8940532ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTORCCK1989-07-20
838981034902680K890484HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBEFLL1989-04-21
838981935266347K890484HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBEFLL1989-04-21
838991986902865K890288PERITONEAL CATHETERS WITH AN ADDED FUNCTIONFJS1989-03-27
838981293443359K890194SHILEY SPECIALIZED TRACHEOSTOMY TUBEJOH1989-07-20
838981969800784K890193SINGLE PATIENT USE NASAL (CPAP) CIRCUITBYG1989-03-14
838991969800784K890193SINGLE PATIENT USE NASAL (CPAP) CIRCUITBYG1989-03-14
838981671246008K884730SHILEY PERC TRACHEOSTOMY SYSTEMBTO1989-01-17
838991255016305K883201VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYSHBI1988-09-26
838981234956692K882329L-F COILED EXTENSION TUBINGDXT1988-09-02
838991234956692K882329L-F COILED EXTENSION TUBINGDXT1988-09-02
838981702680991K882130FOLEY-TEMP(TM)EYB1988-08-09
838991299345603K882097TUNNELING STYLETDRB1988-07-28
838981357430052K875234MON-A-THERM'S SKIN TEMPERATURE SENSORFLL1988-01-19
838981705377127K875226ESOPHAGEAL OBTURATOR/TRACHEAL TUBECAO1988-01-19
838982036204500K874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORKRI1988-02-02
838981672158068K874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEFLL1988-01-29
838981929307449K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSORFLL1987-11-06
838981923547490K873525DEKNATEL TROCAR CATHETERJOL1987-11-02
838991056947938K871730MODIFIED USE OF PULL-APART INTRODUCER SETFKO1987-05-18
838981982778552K871204CUFFED TRACHEAL TUBE (MULTIPLE)BTR1987-04-21
838991598080325K862288MODIFICATION OF TISSUE DILATORDRE1986-08-19
838991447367530K862046SWAN-NECK PERITONEAL DIALYSIS CATHETERSFJS1986-06-19
838991621321772K861036E7509 POLYHESIVE II PATIENT RETURN ELECTRODEGEI1986-05-06
838991071277721K860484CURITY & KENGUARD SILICONE COATED FOLEY CATHETERKOD1986-03-11
839001867545786K860373THE M100 AIR/OXYGEN MIXERBZR1986-05-21
838981827185726K853392MON-A-THERM SUBCUTANEOUS TEMP. SENSORFLL1985-11-22
838981798510248K852632GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUBCAI1986-01-03
838991798510248K852632GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUBCAI1986-01-03
838991987495063K850214STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM INFJS1985-07-26
838991228758589K844789KANGAROO ACCESS II ENTERAL FEEDING CONTAINERKNT1985-01-02
838991438685231K844193QUINTON INJECTION SEALING CAPFOZ1985-05-17
838981427551462K843730SHILEY DISPOS. DECANNULATION PLUG W/SW/BTO1984-10-19
838981272589959K841872UNCUFFED REINFORCED TRACHEAL TUBEBTR1984-07-26
838991313962982K841092HIGH PRESSURE FLEX. CONNECTING TUBINGDXT1985-07-24
838991552159944K840815LUER LOCKING ADAPTER(MATERIAL CHANGE)FOZ1984-11-08
838991955582171K834062STERILE LABELSLDQ1984-02-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CBK312020-11-20
DQA252022-05-06
GEI192023-03-23
FLL122024-08-20
JOH122019-03-22
BTR112024-05-20
FJS92018-07-27
CCK82021-09-17
CAH71996-11-26
KOD62004-07-07
MUD52021-12-05
MSD52013-01-31
DXT52004-11-30
KNT52004-11-05
BTO51995-02-27
LZH42015-05-29
KRD42015-04-22
BTM42003-02-07
CAF42002-08-07
BYD41995-06-08
BYE41994-07-06
FFX32023-07-21
MPB32020-01-17
DWJ32013-07-29
MWI32013-02-27
BZD32000-09-06
FOZ31991-10-02
BZT22025-12-29
PIE22017-11-22
BZQ22012-03-15
BZG22002-09-27
GIM21992-07-10
BYG21989-03-14
CAI21986-01-03
EOX12018-08-16
PID12013-10-07
NFK12009-11-19
NLF12004-12-13
HFX12004-04-09
EZL12003-06-11